Job Details

Title: Clinical Data Manager II

Location: South San Francisco, CA 94080

Duration: 12-Month Contract

Hybrid 3 days onsite/ 2 days WFH

The Opportunity

We are seeking a Clinical Data Manager II to client USMA Data Management team. This role sits within a highly collaborative environment focused on end-to-end data lifecycle management, supporting exploratory research, clinical development, and evidence generation.

You will act as a data quality leader, ensuring high-quality, compliant clinical data while driving innovative data solutions aligned with FAIR (Findable, Accessible, Interoperable, Reusable) principles.

Key Responsibilities

Data Management & Quality

• Oversee collection, validation, and curation of clinical and real-world data
• Develop and manage clinical databases ensuring accuracy and integrity
• Perform high-level data reviews using visualization and statistical monitoring tools
• Identify trends, anomalies, and gaps in datasets

Study & Project Oversight

• Manage timelines, risks, and deliverables across multiple studies
• Ensure successful execution of study scope of work (SOW)
• Maintain accountability for data quality and regulatory compliance

Vendor & Stakeholder Management

• Partner with FSPs, CROs, and external vendors to oversee deliverables
• Manage data transfer agreements and ensure adherence to standards
• Collaborate cross-functionally with biometrics, clinical teams, and business stakeholders

Data Strategy & Innovation

• Design and implement fit-for-purpose data solutions
• Support collection of diverse data types (e.g., biomarkers, EMR, sensor data)
• Contribute to enterprise-wide initiatives and emerging technologies
• Apply FAIR principles to optimize data usability and accessibility

Leadership & Technical Expertise

• Provide guidance to data management teams and stakeholders
• Act as SME for data acquisition, standards, and best practices
• Represent Data Management in study team and data quality meetings

Required Qualifications:

• 5–10 years of Clinical Data Management experience
• Bachelor's or Master's degree in Life Sciences, Data Science, Bioinformatics, or related field
• Strong knowledge of ICH-GCP and regulatory requirements
• Experience with CDISC standards (SDTM preferred)
• Proven project management and stakeholder management skills
• Strong analytical, problem-solving, and communication abilities

Preferred Qualifications

• Experience leading DM activities across multiple clinical studies
• Familiarity with EDC systems (e.g., Medidata Rave, Oracle Clinical)
• Experience with Real World Data (RWD) and advanced data sources
• Proficiency in tools/languages such as SAS, R, Python, SQL
• Experience with data visualization tools (Tableau, Shiny)
• Knowledge of MedDRA, WHODrug, and advanced analytics (AI/ML)
• Exposure to big data tools (Hadoop, Spark)